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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01260441
Other study ID # CRS-807120
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2007
Est. completion date October 2012

Study information

Verified date October 2018
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Each year in the United States, 300,000 people suffer from a Cardiac Arrest (CA), and of them, there is a 90% mortality rate. Out-of-Hospital arrests, in particular, have a 1-5% survival to hospital discharge. High quality CPR is crucial to lowering the mortality rate and increasing survival, yet only 15-30% of out-of-hospital CA victims receive bystander CPR. Studies have shown that prompt administration of CPR dramatically improves outcomes. In a recent study from Switzerland, lay bystander CPR doubled the survival rate at one month. Our study will look to train family members of at-risk cardiac patients in the skills of CPR through the American Heart Association's (AHA) CPR Anytime Friends and Family Personal Learning Program (CPR Anytime) to see if these family members are able to learn and perform quality CPR in the event that their family member should suffer a cardiac arrest.


Description:

Using the AHA's CPR Anytime kit, we will work with family members of patients at high risk for a CA to learn lifesaving CPR skills. We will modify the AHA CPR video using the new AHA recommendations for bystanders which suggests doing chest compression only CPR. Using the original AHA video and our modified chest compression only video, we will randomize family members of patients at high risk for CA to one of these groups. Our research assistants will also be blinded to which video these subjects will be watching. After watching the video, we will have the subjects perform CPR on a mannequin using a CPR recording device that records chest compression rate and depth. We will follow up with the family members at 3 months, 6 months and 12 months to see if they retained their CPR knowledge and skills and to see if they had been in a situation where their CPR skills were needed and assess whether they performed their skills or not. We will also measure the number of people with whom the subjects shared their CPR Anytime kits—a quantity known as the multiplier effect to determine if they had shared the CPR Anytime kit with their family and friends, thereby increasing the possible number of lay persons trained in CPR and in turn able to perform bystander CPR if needed.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Family member's of patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.

Exclusion Criteria:

- If someone is physically unable to undergo CPR Training

- Someone who has received CPR training in the past 2 years

Study Design


Intervention

Other:
CPR Training using the Family and Friends CPR Anytime VSI Kit
Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit. Subjects will undergo training in-hospital and will be encouraged to take the kit home to share with their family members and friends.

Locations

Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Penn Presbyterian Medical Center Philadelphia Pennsylvania
United States Pennsylvania Hospital Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject Self-Confidence We will administer a comprehensive post-training likert scale scoring survey to measure the subject's comfort level using their newly acquired CPR skills. within 30 minutes of CPR training
Primary Secondary Training In addition, we will administer a telephone survey to measure the subject's secondary training through the CPR Anytime Kit. 3 month increments over a 12 month period of time
Secondary Assessing CPR Skills We will assess the subject's CPR skills by administering a 2-minute simulated CPR skills check recorded on a Laerdal Skillreporter ResusciAnne mannequin and video camera. The skills check will be conducted initially post training and at the 3-, 6-, and 12-month time frame. 3 to 6 months post-training
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